Investigation of a medical device (ipalat® Hydro Med Lutschpastille) on saliva production andon changes in salivary surface tension in healthy subjects with dry mouth

Not Applicable

• Conditions: R68.2; Dry mouth, unspecified

• Registration Number: DRKS00017393
• Lead Sponsor: Dr. Pfleger Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Study Completion: 2019-06-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Healthy male, female and diverse subjects at least 18 years of age
-Written informed consent
-Willingness to actively participate in the study
-Dry mouth (xerostomia 10.3.3) at least 40 mm VAS (total length 100 mm, ranging from not
dry to extremely dry)
-Willingness to avoid heavy sweating (e.g. sauna, sport, swimming) one day prior to the
measurements
-Willingness not to eat spicy or salty foods, including garlic and onions one day prior to the
measurements
-Willingness not to consume alcohol extensively in the evening prior to the measurements
-Willingness to avoid excitement (e.g. exams, tests) in the morning prior to the measurements
-Willingness to avoid food with a saliva reducing effect (e.g. alcohol, caffeine-containing
beverages, sugar-containing beverages with carbonic acid) 4 hours prior to the measurements
-Willingness to avoid food with a saliva stimulating effect (e.g. citrus fruits, chewing gums, chamomile, sage, marshmallow root) 4 hours prior to the measurements
-Willingness to avoid food requiring extensive chewing (e.g. carrots, apples, celery) 4 hours
prior to the measurements
-Willingness not to smoke 4 hours prior to the measurements
-Willingness not to eat or drink (except water) within 90 minutes prior to the measurements
-Willingness not to change the prosthesis or artificial dentition throughout the course of the
study
-Willingness to inform the study site in case of changes in therapies especially regarding the
medication which caused xerostomia
-Negative urine pregnancy test (in female subjects of child bearing potential).

Exclusion Criteria

-Poor general health condition -Pregnancy or lactation -Drug addicts, alcoholics, AIDS or infectious hepatitis if known to the subjects -Conditions which exclude a participation or might influence the test reaction/evaluation -Active disease at test area -Subjects suffering from diseases of the salivary glands -Subjects suffering of dental or other problems within the oral cavity -Subjects with chewing or swallowing Problems -Systemic therapy with immuno-suppressive drugs and/or antihistamines within the last 7 days (long-term therapy for at least 3 months is allowed) -Xerostomia developed recently (less than 3 months) or due to short term drug intake -Therapy with antibiotics within the last 2 weeks and/or ongoing -Ongoing radiation or chemotherapy throughout the course of the study -Surgery in test area within the last 4 weeks -Fever or gastrointestinal infection within the last 7 days prior to the start of the study -regular intake (=4/d) of chewing gum or pastilles within 2 weeks prior study start -Prosthesis or artificial dentition within the last 4 weeks prior the start of the study and throughout the course of the study -Smoking within the last 4 hours before the scheduled visits -Intake of any food or beverages (except water) within the 90 minutes prior to the
measurements -Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary enpoint is the total salivary flow rate determined after 10 minutes (g/10min) by weighing the tubes containing the collected saliva